February 27, 2015. This is a very brief summary of the concerns of coalition members. The purpose of federal regulations is to protect the U.S. public from harm by implementing reasonable safeguards.
Read More »We’re Speaking Out on Health Issues
NCHR scientists and health policy experts provide written and oral statements on a wide range of topics.
Here are many of the ways we have been Speaking Out on Health Policy Issues for the last few years. Whether the topic is legislation intended to cure diseases, proposed bans on BPA or other chemicals that disrupt your hormones, the importance of including women, people of color, and patients over 65 in clinical trials, or many other topics, you’ll gain a better understanding of our evidence-based analyses by reading these letters, statements, and testimony.
Here are the ways we have been Speaking out on Medical Treatments and Products, such as prescription drugs and medical devices that the FDA is considering approving, or is considering taking off the market because of serious risks. Whether the topic is Chantix, Addyi, Yaz, Essure, or medical products you’ve never heard of, you can find out more about what is known and not known about the safety and effectiveness of a wide range of products by looking through this section of our website.
Testimony at the FDA on Joint Dermatologic and Ophthalmic Drugs Advisory Committee/Ophthalmic Devices Panel
February 24, 2015. It is clear that patients suffering from Keratoconus or Corneal ectasia need treatment options. The risk-benefit analysis may support approval of corneal cross-linking for those patients, however we are very concerned about the data presented here showing limited efficacy. We are also extremely concerned about off-label use of this risky technology. The incidence of adverse events from the cross-linking procedure is very high, so this procedure should NOT be used except for those diseases/conditions.
Read More »Letter to Congresswoman Rosa DeLauro Supporting “Helping Effective Antibiotics to Last” (HEAL) Act
February 12, 2015. The Centers for Disease Control and Prevention (CDC) points out that two major actions are urgently needed to address the threat posed by antibiotic resistance are: 1) stop the misuse of existing antibiotics, and 2) develop effective new antibiotics. HEAL is the first bill to focus on both these necessary actions.
Read More »Statement of Dr. Zuckerman on FDA Commissioner Hamburg’s Resignation
February 5, 2015. The 21st Century Cures proposed legislation represents a frightening assault on the agency and the safety of medical products, and the FDA will need a very strong leader to protect its public health mission.
Read More »Letter to FDA Commissioner Hamburg on New Antibiotic Product (CAZ-AVI)
December 19, 2014. We are writing to express our strong concerns about the approval standards considered and the conflicts of interest apparent at the December 5, 2014 FDA meeting of the Anti-Infective Drugs Advisory Committee (AIDAC) regarding a new combination antibiotic product, ceftazidime-avibactam (CAZ-AVI).
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